Crystal Clear: Controls Are Not Enough

The case for sustainable education for pharma operators

It is always the same story. Regardless of how far we advance technologically in the world of aseptic processing and medicine, inspection trends remain flat, and warning letters and costly remediations keep chugging along.  

The challenges involved in trying to avoid this not-inevitable fate never seem to be fully and sustainably addressed. 

It is essential and achievable to ensure:

• Sterility of the finished product
• Accuracy in filling volume/amount
• Contemporaneous documentation

Rapid containment, and prevention of contaminants in the environment in which these lifesaving products are produced is essential.

Controls are not enough. One key ingredient is missing and we all know it: Quality and sustainable education of our operators. 

Conventional on-the-job training teaches our operators what they need to do, but the “why” is rarely taught or understood. From understanding the principles of “first air” (maintaining the unidirectional flow of the air stream leaving the HEPA filters by walking and moving with purpose) to proper hygiene to principles of gowning, the “why” is very important. Teaching the “why” elevates the training to education. 

The need is obvious, so QxP and I created Virtuosi (https://www.virtuosivr.com/), a comprehensive on-demand training and education program with courses led by industry veterans. 

Virtuosi delivers an in-depth approach that provides clarity, confidence, and consistency in your operation, no matter where your operators are located in the world. 

It is essential, and achievable, to release quality products to the patient the first time and every time.  Let me know if you have any questions. 

To learn more about why the experts at QxP developed Virtuosi, go to QxP founder Crystal Mersh's blog, "Crystal Clear: Controls are not enough."

QxP Founder and CEO Crystal Mersh’s career in pharma quality has spanned three decades and huge companies. Prior to founding QxP in 2012, Crystal has worked in leadership roles at Mylan, Novartis, Watson Pharmaceuticals, and Sanofi.

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